Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
PREMIER
1 other identifier
observational
500
1 country
5
Brief Summary
The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT) in standard of care (SOC) use in the treatment of local,loco-regionally advanced, and oligometastatic malignancies. In addition, patient costs and charges will be analyzed to quantify the health economic impact of this modality. Workflow and quality of radiotherapy planning including a collection of dosimetric data will also be analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2022
CompletedFirst Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
June 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2026
CompletedAugust 15, 2025
August 1, 2025
4 years
May 2, 2022
August 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Health Related Quality of Life (HRQOL) scores
Evaluate patient-reported quality of life after IMRT, SBRT, or BgRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30. The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.
30 Days
Health Related Quality of Life (HRQOL) scores
Evaluate patient-reported quality of life after IMRT or SBRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30. The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.
90 Days
Secondary Outcomes (10)
Long Term Health-Related Quality of Life-EORTC
6 months, 9 months, 12 months, 18 months, and 24 months
Long Term Health Related Quality of Life-EuroQol
6 months, 9 months, 12 months, 18 months, and 24 months
Acute toxicities related to Radiotherapy treatment
Up to 90 days
Disease Status [progression-free survival]
Through Study Completion, average of 2 years
Disease Status [local recurrence]
Through Study Completion, average of 2 years
- +5 more secondary outcomes
Study Arms (3)
Stereotactic Body Radiotherapy [SBRT]
Patients treated with Reflexion X1 with SBRT as the standard of care
Intensity -Modulated Radiation Therapy [IMRT]
Patients treated with Reflexion X1 with IMRT as the standard of care
Biology-guided Radiotherapy [BgRT]
Patients treated with Reflexion X1 with BgRT as the standard of care
Interventions
Observation Registry for Medical Device
Eligibility Criteria
The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), and Biology-guided radiotherapy (BgRT), in standard of care(SOC)use in the treatment of local, locoregionally advanced, and oligometastaticmalignancies. In addition, patient costs and charges will be analyzed to quantify the health economic impact of this modality. Workflow and quality of radiotherapy planning including collection of dosimetric data will also be analyzed.
You may qualify if:
- Able to comprehend and be willing to sign an informed consent form (ICF).
- Diagnosis of local, loco-regionally advanced, or metastatic malignancy for whom radiotherapy is indicated
- Radiotherapy to be delivered on the RMRS X1 with IMRT, SBRT, or BgRT technique.
- Absence of concurrent illness that deems radiotherapy a contraindication which will be determined by the treating radiation oncologist.
- Female and male patients of child-bearing potential willing to take appropriate precautions to avoid pregnancy while being treated. Permitted methods in preventing pregnancy should be communicated to the patient and their understanding confirmed by the treating Physician.
- For BgRT patients only: Deemed eligible for BgRT with FDG per BgRT planning session
You may not qualify if:
- Pregnant or expecting to conceive during the study.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with study requirements and follow-up visits.
- Inability to maintain immobilization, supine position for planning and treatments.
- For BgRT patients only: Known allergy to FDG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
City Of Hope
Duarte, California, 91010, United States
Stanford Cancer Center
Palo Alto, California, 94305, United States
Yale University - Cancer Center
New Haven, Connecticut, 06510, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219, United States
UT Southwestern
Dallas, Texas, 75235, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sean Shirvani, MD
RefleXion Medical
- STUDY DIRECTOR
Karine Feghali, MD
RefleXion Medical
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
June 6, 2022
Study Start
April 12, 2022
Primary Completion
April 25, 2026
Study Completion
April 25, 2026
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share